Double-Blind

  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9194d34e3ec86e4a031b9c27f0897386' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of selenium may keep bladder cancer from growing or coming back. It is not yet known whether selenium is more effective than a placebo in preventing cancer recurrence in patients with bladder cancer. PURPOSE: This randomized phase III trial is studying selenium to see how well it works compared with a placebo in preventing cancer recurrence in patients with bladder cancer.</p>\n', created = 1283574892, expire = 1283661292, headers = '', serialized = 0 WHERE cid = '1:9194d34e3ec86e4a031b9c27f0897386' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:dd25aca53c846467dcf909cd09de6cf0' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Phase III Randomized Chemoprevention Study of Selenium on the Recurrence of Non-Invasive Bladder Cancer</p>\n', created = 1283574892, expire = 1283661292, headers = '', serialized = 0 WHERE cid = '1:dd25aca53c846467dcf909cd09de6cf0' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:de1ba0da6885c724bdf73ca89420aef2' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>OBJECTIVES: Primary\n<ul>\n<li>To determine the effect of selenium, when administered with standard care, in preventing the recurrence of bladder cancer in patients with non-muscle-invasive transitional cell carcinoma of the bladder at risk for recurrence.</li>\n</ul>\n</p><p> Secondary\n<ul>\n<li>To determine the effect of selenium on the recurrence of bladder cancer, in terms of histological type, number, and size.</li>\n</ul>\n</p><p> OUTLINE: Patients are randomized to 1 of 2 treatment arms.\n<ul>\n<li>Arm I: Patients receive oral placebo daily in addition to standard care.</li>\n<li>Arm II: Patients receive oral selenium daily in addition to standard care.</li>\n</ul>\n</p>', created = 1283574892, expire = 1283661292, headers = '', serialized = 0 WHERE cid = '1:de1ba0da6885c724bdf73ca89420aef2' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:2ecedb2aa64cb8223a01cc43c2db271d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>DISEASE CHARACTERISTICS:\n<ul>\n<li>Histopathologically confirmed non-muscle-invasive transitional cell carcinoma (TCC) of the bladder (&lt; pT2 ), meeting any of the following criteria:\n<ul>\n<li>Solitary grade 1, pTa (&#8805; 3 cm) tumor</li>\n<li>Any other pTa, pTis (carcinoma in situ), or pT1 tumor</li>\n</ul>\n</li>\n<li>Newly diagnosed disease</li>\n<li>Meets 1 of the following risk criteria for recurrence:\n<ul>\n<li>Intermediate-risk disease\n<ul>\n<li>Multiple grade 1, pTa (&gt; 1) tumor</li>\n<li>Solitary grade 1, pTa (&#8805; 3 cm) tumor</li>\n<li>Grade 2, pTa tumor</li>\n<li>Grade 1, pT1 tumor</li>\n<li>Grade 2, pT1 (1 or 2 tumors)</li>\n</ul>\n</li>\n<li>High-risk disease\n<ul>\n<li>Grade 3, pTa tumor</li>\n<li>Grade 3, pT1 tumor</li>\n<li>Tis (carcinoma in situ)</li>\n<li>Multiple grade 2, pT1 (&#8805; 3 foci) tumor</li>\n</ul>\n</li>\n</ul>\n</li>\n<li>Has undergone diagnostic transurethral resection of the bladder tumor/biopsy within the past 3 months\n<ul>\n<li>No residual tumor, defined as a recurrence within 3 months after initial treatment (due to incomplete resection of the primary index tumor or implantation after biopsy)</li>\n<li>No prostatic, prostatic urethral, or upper tract TCC involvement by the index tumor at resection</li>\n</ul>\n</li>\n<li>No muscle invasion or advanced disease</li>\n<li>No metastatic disease</li>\n</ul>\n</p><p> PATIENT CHARACTERISTICS:\n<ul>\n<li>Able to swallow pills</li>\n<li>Not pregnant</li>\n<li>Fertile patients must use effective contraception</li>\n<li>No other malignancy within the past 5 years</li>\n<li>No known hypersensitivity or adverse reactions to selenium</li>\n<li>No other serious medical or psychiatric illness that would preclude giving informed consent</li>\n<li>No condition that, in the opinion of the investigator, may interfere with the safety of the patient or the evaluation of the study objectives</li>\n</ul>\n</p><p> PRIOR CONCURRENT THERAPY:\n<ul>\n<li>See Disease Characteristics</li>\n<li>More than 30 days since prior daily dietary supplements containing selenium</li>\n<li>No other concurrent selenium (contained in individual supplements, antioxidant mix, or multivitamin) intake</li>\n<li>No concurrent participation in another study involving a medical, surgical, nutritional, or lifestyle intervention\n<ul>\n<li>Concurrent participation in the follow-up phase of another study allowed</li>\n</ul>\n</li>\n</ul>\n</p>', created = 1283574892, expire = 1283661292, headers = '', serialized = 0 WHERE cid = '1:2ecedb2aa64cb8223a01cc43c2db271d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:73e17bcc1a94ebd672b913e6684b1727' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>RATIONALE: Palifermin may help relieve or prevent oral mucositis caused by chemotherapy and radiation therapy in young patients undergoing stem cell transplant. PURPOSE: This randomized phase II trial is studying palifermin to see how well it works compared with a placebo in preventing oral mucositis caused by chemotherapy and/or radiation therapy in young patients undergoing stem cell transplant.</p>\n', created = 1283574892, expire = 1283661292, headers = '', serialized = 0 WHERE cid = '1:73e17bcc1a94ebd672b913e6684b1727' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:df5f8ae469adb8470aa30e5df7c98a46' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Group-Wide Double-Blind Randomized Placebo-Controlled Trial of Palifermin to Prevent Chemotherapy and/or Radiotherapy Induced Oral Mucositis in Children Undergoing Autologous or Allogeneic Hematopoietic Stem Cell Transplantation</p>\n', created = 1283574892, expire = 1283661292, headers = '', serialized = 0 WHERE cid = '1:df5f8ae469adb8470aa30e5df7c98a46' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a35da0cfa0a7a86f6409af67c4b7bd98' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>OBJECTIVES: Primary\n<ul>\n<li>To compare whether palifermin versus placebo administered to pediatric patients three days prior to conditioning and three days after autologous or allogeneic hematopoietic stem cell transplantation (HSCT) is associated with a reduction in the incidence of WHO grade 3 or 4 oral mucositis.</li>\n</ul>\n</p><p> Secondary\n<ul>\n<li>To evaluate the safety and tolerability of palifermin.</li>\n<li>To evaluate the long-term effects of palifermin on disease outcome and survival.</li>\n<li>To compare the incidence, total dose, and duration of parenteral opioid analgesic use (morphine equivalents), and incidence and duration of total parenteral nutrition (TPN) administration in patients treated with these regimens.</li>\n<li>To compare the incidence of febrile neutropenia and invasive bacterial infections in patients treated with these regimens.</li>\n<li>To determine whether palifermin versus placebo reduces the incidence of WHO grade 3 or 4 oral mucositis among allogeneic HSCT pediatric patients receiving methotrexate as graft-versus-host disease (GVHD) prophylaxis.</li>\n<li>To determine whether palifermin versus placebo reduces acute and chronic GVHD after allogeneic HSCT.</li>\n<li>To describe health care utilization (hospitalization duration, and administration of antibiotics, TPN, nasogastric-, nasojejunal- or gastrostomy-administered enteral nutrition, and blood products) in pediatric patients treated with these regimens.</li>\n</ul>\n</p><p> OUTLINE: This is a multicenter study. Patients are stratified according to age in years (1 to 2 vs 3 to 11 vs 12 to 16), type of hematopoietic stem cell transplantation (HSCT) (autologous vs allogeneic), conditioning regimen (either total-body irradiation [TBI] or melphalan vs neither TBI nor melphalan). Patients are randomized to 1 of 2 treatment arms.\n<ul>\n<li>Arm I: Patients receive palifermin IV once daily for 3 days prior to chemotherapy and/or radiotherapy in the absence of unacceptable toxicity.</li>\n</ul>\n</p><p> Patients then receive palifermin IV on days 0, 1, and 2 after autologous or allogeneic HSCT.\n<ul>\n<li>Arm II: Patients receive placebo IV once daily for 3 days prior to chemotherapy and/or radiotherapy in the absence of unacceptable toxicity. Patients then receive placebo IV on days 0, 1, and 2 after autologous or allogeneic HSCT.</li>\n</ul>\n</p><p> Blood samples are collected at baseline, 32 days, and 100 days after HSCT to evaluate the immunogenicity of palifermin. Oral mucositis is assessed at baseline, daily for 8 days prior to and 32 days after HSCT, or until oral mucositis has resolved by the WHO Mucositis Scale, Oral Mucositis Assessment Scale (OMAS), modified Walsh mucositis scale, Oral Mucositis Daily Questionnaire (OMDQ), and the pain categorical rating scale. After completion of HSCT, patients are followed periodically for up to 10 years.</p>\n', created = 1283574892, expire = 1283661292, headers = '', serialized = 0 WHERE cid = '1:a35da0cfa0a7a86f6409af67c4b7bd98' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:bb95235845e20e6a675762a6d3f40d7e' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>DISEASE CHARACTERISTICS:\n<ul>\n<li>Patients undergoing myeloablative autologous or allogeneic hematopoietic stem cell transplantation (HSCT) for any indication</li>\n<li>Any type of myeloablative HSCT conditioning regimen allowed</li>\n<li>Patients undergoing allogeneic HSCT may undergo 1 of the following types of donor stem cells:\n<ul>\n<li>HLA-matched sibling or parent</li>\n<li>Partially matched family donor (mismatched for a single HLA locus [class I])</li>\n<li>Fully matched unrelated marrow or peripheral blood stem cell donor</li>\n<li>HLA-matched or partially mismatched (at least 4 of 6 match) cord blood (class I or II)</li>\n</ul>\n</li>\n</ul>\n</p><p> PATIENT CHARACTERISTICS:\n<ul>\n<li>Not pregnant or nursing</li>\n<li>Negative pregnancy test</li>\n<li>Fertile patients must use effective contraception</li>\n<li>No HIV positivity</li>\n<li>No known sensitivity to any E. coli-derived products\n<ul>\n<li>Known grade 1 to 2 allergic reactions to asparaginase allowed</li>\n<li>No prior grade 3-4 allergies to asparaginase or pegaspargase</li>\n</ul>\n</li>\n</ul>\n</p><p> PRIOR CONCURRENT THERAPY:\n<ul>\n<li>See Disease Characteristics</li>\n<li>More than 30 days since prior and no concurrent treatment with any of the following therapies:\n<ul>\n<li>Oral cryotherapy</li>\n<li>Glutamine as an oral supplement</li>\n<li>Traumeel&#174;</li>\n<li>Gelclair&#174;</li>\n<li>Oral vancomycin paste</li>\n<li>Low-level laser therapy</li>\n<li>An investigational product or device in another clinical trial</li>\n</ul>\n</li>\n<li>No prior palifermin or other keratinocyte growth factors</li>\n<li>No other concurrent cytotoxic drugs for conditioning or graft-vs-host disease prophylaxis\n<ul>\n<li>Intrathecal methotrexate or cytarabine for CNS involvement allowed</li>\n</ul>\n</li>\n</ul>\n</p>', created = 1283574892, expire = 1283661292, headers = '', serialized = 0 WHERE cid = '1:bb95235845e20e6a675762a6d3f40d7e' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:ec6dbdc887d16cd51563c4748d35fa7e' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Safety and tolerability of palifermin [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283574892, expire = 1283661292, headers = '', serialized = 0 WHERE cid = '1:ec6dbdc887d16cd51563c4748d35fa7e' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8eebff6f10ca6c1fd499b9e8948d715b' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Long-term disease outcome and survival [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574892, expire = 1283661292, headers = '', serialized = 0 WHERE cid = '1:8eebff6f10ca6c1fd499b9e8948d715b' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:0ba2af343f300b31fc7e925de958cb39' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Duration of WHO grade 3 or 4 oral mucositis [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574892, expire = 1283661292, headers = '', serialized = 0 WHERE cid = '1:0ba2af343f300b31fc7e925de958cb39' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:efda079bce71216266982e184ec19e9c' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Incidence, total dose, and duration of parenteral opioid analgesic use (morphine equivalents) [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574892, expire = 1283661292, headers = '', serialized = 0 WHERE cid = '1:efda079bce71216266982e184ec19e9c' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:02fac6ce9cae062f7b8ef9c212258471' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Incidence and duration of total parenteral nutrition administration [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574892, expire = 1283661292, headers = '', serialized = 0 WHERE cid = '1:02fac6ce9cae062f7b8ef9c212258471' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9e8fe591e820bb46408a222bc02fcaff' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Incidence of febrile neutropenia and invasive bacterial infections [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574892, expire = 1283661292, headers = '', serialized = 0 WHERE cid = '1:9e8fe591e820bb46408a222bc02fcaff' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a24c53e1e9c2beb430185cc3a2a2a849' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Incidence of WHO grade 3 or 4 oral mucositis among allogeneic HSCT patients receiving methotrexate as GVHD prophylaxis [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574892, expire = 1283661292, headers = '', serialized = 0 WHERE cid = '1:a24c53e1e9c2beb430185cc3a2a2a849' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:4d84bcb8e25523003f9e0c8a53ba6cfa' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Incidence of acute and chronic GVHD after allogeneic HSCT [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574892, expire = 1283661292, headers = '', serialized = 0 WHERE cid = '1:4d84bcb8e25523003f9e0c8a53ba6cfa' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:691942a1d6e9235aa1fe7f2d68315455' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Health care utilization [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574892, expire = 1283661292, headers = '', serialized = 0 WHERE cid = '1:691942a1d6e9235aa1fe7f2d68315455' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9b437d533bf2c90ce5bb8ed4912f21ce' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Phase II study in patients with acute exacerbation of schizophrenia. The primary objective is to evaluate the efficacy via the changes from baseline in the total Positive and Negative Syndrome Scale (PANSS) score of three fixed doses of JNJ-37822681 compared with placebo after 6 weeks\' treatment in patients with schizophrenia</p>\n', created = 1283574892, expire = 1283661292, headers = '', serialized = 0 WHERE cid = '1:9b437d533bf2c90ce5bb8ed4912f21ce' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:d48a7956ac4edc204c5f2971de453644' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is to evaluate the pharmacokinetics of golimumab.</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:d48a7956ac4edc204c5f2971de453644' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:6886f8b18c56dde54e911a2fa71e35b8' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Study of Golimumab (CNTO 148) Administered in Combination With Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:6886f8b18c56dde54e911a2fa71e35b8' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9189e38d5b4d4298e9479459124822dc' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This clinical study is scheduled to be performed for the purpose of evaluating the safety and effectiveness of golimumab (CNTO148) administered in combination with stable dose (6-8mg/week) of methotrexate (MTX) to patients with rheumatoid arthritis (RA). CNTO148 50 mg group: CNTO148 50 mg SC injections every 4 weeks from the first administration until week 152. If early escape, 100 mg SC injections every 4 weeks from week 16 until week 152. CNTO148 100 mg group: CNTO148 100 mg SC injections every 4 weeks from the first administration until week 152 whether early escape or not Placebo group: Placebo SC injections every 4 weeks from the first administration until week 20 and then CNTO148 50mg SC injections every 4 weeks from week 16 until week 152</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:9189e38d5b4d4298e9479459124822dc' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:5426fb797811214b901bff72d0ad208c' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Patients diagnosed with rheumatoid arthritis at least 3 months prior to registration and who are definitely identified as having rheumatoid arthritis, at the time of informed consent, according to the criteria for classification established by the American College of Rheumatology (1987)</li>\n<li>Patients in whom MTX therapy (&gt;= 6 mg/week) was started more than 3 months before the first administration and who have been treated with MTX at a stable dose (6-8 mg/week) for at least 4 weeks before the first administration</li>\n<li>Patients having at least 4 swollen joints and at least 4 tender joints at the time of registration and immediately before the first administration</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Patients with a history of hypersensitivity to human immunoglobulin proteins or other ingredients of golimumab</li>\n<li>Patients who have previously experienced or are suffering from any of the following diseases: (i) Collagen diseases other than rheumatoid arthritis, (ii) Latent or active granulomatous infections such as histoplasmosis and coccidioidomycosis, (iii) Felty syndrome, etc</li>\n<li>Patients with a severe, advanced, or poorly controlled disease in any of the kidney, liver, blood, gastrointestinal system, endocrine system, lung, heart, nervous system, psychiatric system, and brain</li>\n</ul>\n</p>', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:5426fb797811214b901bff72d0ad208c' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:0667820789dadb104f773616b17dd67b' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Lateral episiotomy is a current care practiced with childbirth room. One of the problems encountered with this surgical act is the residual pain on perineal scar level. Maximal during the first 24 hours, this pain can persist several days or several weeks hampering to variable degrees a normal recovery of autonomy and comfort of life. Some studies have shown the interest of ropivacaine, local anaesthetic with a long action\'s duration for proctologic surgeries and for the cure of inguinal hernia. A recent study shown the ropivacaine perineal infiltration used prior perineorrhaphy allows an absence of post-partum pain for 24 to 27% of cases and a first analgesics request delayed to ten hours. Methodology: 165 parturients having an epidural analgesia and an episiotomy were enrolled. The perineal infiltration was randomized according to 3 equal groups (placebo, ropivacaine 0,75%, lidocaine 1%) and realised prior perineorrhaphy. then The parturient were followed during the 24 first hours. This study was designed as double blind and the study conduct was standardized in order to get only variable such as the episiotomy infiltration.</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:0667820789dadb104f773616b17dd67b' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:7a2eb3c9e99ca5fd43ccc1bf9a79ab09' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Comparison Of The Analgesia Obtained By Infiltration Of Lidoca&#239;ne 1% And Ropivaca&#239;ne 0,75% Versus Placebo For The Joinings Of Episiotomies Among Parturients Under Epidural Analgesia</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:7a2eb3c9e99ca5fd43ccc1bf9a79ab09' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:4014520804349604404c06904872d12c' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Pre-inclusion criteria :\n<ul>\n<li>Assent of participation in the study signed</li>\n<li>Major parturient (&gt; 18 years) in the course of work in room of childbirth</li>\n<li>Mono-foetal pregnancy</li>\n<li>Presentation at the top</li>\n</ul>\n</p><p> Inclusion Criteria:\n<ul>\n<li>Checking of the criteria of pre-inclusion</li>\n<li>Oral confirmation of the assent of the patient</li>\n<li>ASA 1 or 2</li>\n<li>Childbirth by low way</li>\n<li>Patient having an epidural analgesia</li>\n<li>Patient having an episiotomy</li>\n<li>Counter-indication with the ropivaca&#239;ne</li>\n</ul>\n</p><p> Pre-exclusion criteria :\n<ul>\n<li>Absence of signed assent of participation in the study</li>\n<li>Counter indication with the lidoca&#239;ne</li>\n<li>General counter-indications suitable for the epidural anaesthesia , independently of the local anaesthetic used</li>\n<li>Counter-indications with the infiltration: patient under anticoagulants, coagulopathy</li>\n<li>Allergy to the lidocaine or the ropivacaine</li>\n<li>Allergy to the one of analgesics per bones used in the assumption of responsibility of routine</li>\n<li>Severe insufficiency hepatic and/or renal and/or ulcerates gastro-duod&#233;nal (in the case of anti-inflammatory drug regulation not steroid during the postpartum)</li>\n<li>Minor</li>\n<li>Major protected within the meaning of the law Huriet</li>\n<li>Patient during one time of exclusion following another biomedical study</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Absence of oral confirmation of the assent of the patient</li>\n<li>Infection or ignition of the point of puncture</li>\n<li>Analgesia epidural not functional</li>\n<li>Dural breach</li>\n<li>Appearance of ascribable side effects to only the anaesthetic buildings at the time of epidural analgesia</li>\n<li>Median Episiotomy (increased risk of lesions of the sphincter)</li>\n<li>Need for an instrumentation at the time of expulsion</li>\n<li>Haemorrhage of the delivery requiring a blood transfusion and/or general anaesthesia in urgency with surgical operation for haemostasis</li>\n</ul>\n</p>', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:4014520804349604404c06904872d12c' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:3a0a1aded1e9dcd07d530fca45cee5b0' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>To compare between the 3 groups the mean level of the pain during the first 24 hours following the joining of the episiotomy, measured by EVA [&nbsp;Time&nbsp;Frame:&nbsp;24 hours&nbsp;]</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:3a0a1aded1e9dcd07d530fca45cee5b0' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:166dfc5dcd53ff2d0fe48d7463a5bdb0' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>To compare between the 3 groups the analgesics overall consumption per os during the first 24 hours following the joining of the episiotomy [&nbsp;Time&nbsp;Frame:&nbsp;24 hours&nbsp;]</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:166dfc5dcd53ff2d0fe48d7463a5bdb0' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:ad3f73498f6eba61b1c1a05fe41d8dcc' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>To compare between the 3 groups the total cost of the analgesics consumption (local anaesthetic employed and analgesics per bone) during the first 24 hours following the joining of the episiotomy [&nbsp;Time&nbsp;Frame:&nbsp;24 hours&nbsp;]</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:ad3f73498f6eba61b1c1a05fe41d8dcc' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:5eadc3d6c77dacfa5cdb0d940670c1ce' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The purpose of this study was to evaluate by histology and histomorphometry, thirty human osseous biopsies sampled from fifteen patients (2 biopsies per patient) following 3 months of implantation. This study is part of a splitting-blind clinical investigation to compare the performance and safety of INION GTRTM Biodegradable Membrane System to resorbable bilayer Bio-Gide&#174;-membrane of Geistlich biomaterials in enhancing bone regeneration after removal of wisdom teeth. The bone defect and alveolar cavity were augmented with Spongostan&#174; dental 1x1x1cm, Johnson &amp; Johnson, Spreitenbach, Switzerland. The extraction sites were covered on one side with an INION GTRTM Biodegradable Membrane System and on the other with Geistlich resorbable bilayer Bio-Gide&#174;-membrane. This study was conducted in adaptation to the ISO 10993 Standard : Biological Evaluation of Medical Devices, Part 6 (2007): Tests for Local Effects after Implantation. This study was conducted in accordance with the requirements of the FDA (Department of health and human services) Good Laboratory Practice (GLP) Regulations, 21 CFR 58 (revised as of April 01, 2005) and in accordance with the requirements of the OECD Good Laboratory Practices, reference ENV/MC/CHEM (98) 17, adapted by council on November 26th 1997.\n<ul>\n<li>Trial with medical device</li>\n</ul>\n</p>', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:5eadc3d6c77dacfa5cdb0d940670c1ce' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:f595e6172b3cfe863857f5c6e88c1ee9' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion criteria: Females or males between the age of 18 to 30 Subject for extraction of both lower fully impacted wisdom teeth Signed informed consent Able and willing to comply with all study procedures Exclusion criteria: Heavy smoker (&gt;20/day) Insulin dependant diabetes Pregnant or nursing</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:f595e6172b3cfe863857f5c6e88c1ee9' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:ba22d134d44c1184d02e3d50d000e0db' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients.</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:ba22d134d44c1184d02e3d50d000e0db' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:11ad5fd5b0fddba655c3442d50119323' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Placebo-Controlled, Randomized, Double-Blind, Multicenter Study, to Demonstrate the Efficacy of 12 Weeks of Treatment With USL-221 on Moderate to Severe Vasomotor Symptoms and Vulvar/Vaginal Atrophy in Postmenopausal Patients</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:11ad5fd5b0fddba655c3442d50119323' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:291d20af84b58e30958c8b60a9c79f56' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Postmenopausal women</li>\n<li>Have moderate to severe hot flashes</li>\n<li>Normal Pap Smear</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Abnormal mammogram</li>\n<li>Abnormal clinical breast exam</li>\n<li>BMI &gt;35</li>\n</ul>\n</p>', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:291d20af84b58e30958c8b60a9c79f56' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:21e3dc35a1e46a6c9f7716c35514b75e' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Superficial injection of Botulinum toxin has been advocated for cosmetic purposes but has also been reported to be helpful for some pain conditions. We have observed prolonged profound analgesia following subcutaneous superficial injection of Botulinum Toxin Type A (BTA) in patients with certain types of neuropathic pain. We propose to study if addition of BTA extends pain relief compared to placebo when injected subcutaneously into areas of cutaneous allodynia (the property that a normally non-noxious stimulus is perceived as painful).</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:21e3dc35a1e46a6c9f7716c35514b75e' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:c40f324227ef71dc10e5f807fefdbd8f' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Subcutaneous Botulinum Toxin for Cutaneous Allodynia</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:c40f324227ef71dc10e5f807fefdbd8f' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:30050964ffb88936566ba4ef511672d5' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Post-surgical neuromatous pain patients have marked cutaneous allodynia. Touching their skin with normally non-painful stimuli results in pain. Injected local anesthetics are often effective in providing temporary relief. In the course of clinical practice we have observed that a number of patients with cutaneous allodynia have had marked persistent benefit from subcutaneous injection of Botulinum toxin Type A. Rather than killing targeted neurons, Botulinum toxin type A inhibits release of acetylcholine from cholinergic nerve terminals in a prolonged but ultimately reversible manner. Neuropathic pain and its hallmark allodynia are classically difficult to treat. Standard treatment with tricyclic antidepressants, anti-epileptic drugs, opiates and spinal cord stimulation is frequently disappointing leaving patients with refractory pain. Surgical or percutaneous ablation of involved nerves has fallen out of favor among many due to disappointing results. A pilot study is needed to assess the efficacy of superficially injected Botulinum Toxin type A for treatment of cutaneous allodynia and spontaneous pain among patients with neuropathic pain.</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:30050964ffb88936566ba4ef511672d5' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8749ec59d94087bcea25108f01964ed5' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:- Moderate to severe pain (greater than 2/10) of duration more than 6 months despite previous therapy.\n<ul>\n<li>The patient exhibits at least 80% pain relief following injection of local anesthetic subcutaneously into scar as assessed by change in NRS.</li>\n<li>The patient reports the presence of hyperalgesia, allodynia, dysesthesia, or hypoesthesia surrounding the scar.</li>\n<li>Age 18-100</li>\n<li>Ability to read, write, and converse in English, provide informed consent, and follow study procedures&amp;#xA; Exclusion Criteria:1. Any neuromuscular disorder such as myasthenia gravis, eaton lambert, muscular dystrophy. 2. Any ongoing legal action related to their pain. 3. Allergy to local anesthetics. 4. A current or history of any severe psychiatric disorder. 5. History of any adverse reaction to botulinum toxin. 6. History of botulism. 7. Untreated infection. 8. Coagulopathy. 9. Females - positive pregnancy test 10. Surgery within the past 6 months </li>\n</ul>\n</p>', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:8749ec59d94087bcea25108f01964ed5' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:f8c118f23ce4c000d7f5531152502ca1' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Proportion of patients experiencing a reduction of 2 points or more on NRS, three weeks after injection, compared to baseline NRS</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:f8c118f23ce4c000d7f5531152502ca1' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a8ba692a77bf753c4b1201cfe226206b' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Reduction in area of allodynia and hyperalgesia</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:a8ba692a77bf753c4b1201cfe226206b' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:7b59b31c8a133848d269442e02bdf636' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Improvement in psychosocial function as assessed by outcomes as dictated by the IMMPACT Guidelines</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:7b59b31c8a133848d269442e02bdf636' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:5b03d0c048ce7bc56eb530f649069340' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:5b03d0c048ce7bc56eb530f649069340' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:2d721176a08f0e84084b833930d567c4' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Treatment of Schizoaffective Disorder Using Mifepristone</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:2d721176a08f0e84084b833930d567c4' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:bd511a7fb8d4ad5030f0fd413b336fa3' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>You are invited to participate in a research study which evaluates the effectiveness of mifepristone (RU 486) in rapidly reducing the symptoms associated with schizoaffective disorder. Our group believes that the cognitive deficits (a decline in the ability to think clearly) and psychosis (hallucinations or delusions) exhibited in some affective disorders are driven by an excess of stress hormone effects (hypercortisolemia). Often the origin of this hormonal imbalance is unknown. Current treatment for schizoaffective disorder (characterized by mood swings and hallucinations and/or delusions) involves using a combination of antidepressant medication (for mood elevation), mood stabilizing medications (to prevent extreme high and low moods) and antipsychotic medication (for the correction of altered thinking). While these therapies are often effective, they can take several weeks or longer to work. We hope to uncover a quick, effective, safe therapy for the treatment of individuals with your condition.</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:bd511a7fb8d4ad5030f0fd413b336fa3' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:4a927190a17d2d663d23afa3e46cff8a' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:The subjects will be 30 inpatients or outpatients with schizoaffective disorder. Exclusion Criteria:Subjects must be between the ages of eighteen and seventy-five without major medical problems.</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:4a927190a17d2d663d23afa3e46cff8a' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:6076c33800bff9c0b8b34c104e2ca7f1' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The purpose of this study is to assess the effectiveness and safety of CNTO 1275 in patients with moderate to severe plaque type psoriasis in subcutaneous administration of 45 and 90 mg at weeks 0 and 4 and then every 12 weeks, using placebo as a control.</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:6076c33800bff9c0b8b34c104e2ca7f1' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9f3e8379fee63679fdf8749c57b92c40' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Placebo-Controlled Double-Blind Comparative Study of CNTO1275 in Patients With Plaque Type Psoriasis</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:9f3e8379fee63679fdf8749c57b92c40' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:dc18b24c4d23dfd735a1bba0060bbb2e' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This is a multicenter, randomized (patients assigned study drug by chance), double-blind (neither the patient nor the physician knows the assigned medication name), placebo-controlled, parallel-group comparison study. This study has been planned to examine the effectiveness and safety of CNTO 1275 in Japanese patients with moderate to severe plaque type psoriasis in subcutaneous administration of the drug using placebo as a control. In the study, a clinical dose of the drug will be determined based on the obtained effectiveness and safety and it will be confirmed that similar therapeutic effect and safety can be obtained in this study compared to other phase III studies. The patients will be randomly assigned to one of three treatment groups. Since the double-blind method is employed in this study, two prefilled syringes per dosing will be subcutaneously administered to patients during the treatment period. At 12 weeks and later in the active-drug treatment period, CNTO 1275 will be administered to all patients. [Placebo-controlled treatment period &lt;Weeks 0-12&gt;]: 45-mg group: subcutaneous (s.c.) treatment with CNTO 1275 45 mg (0.5 mL) and placebo (1.0 mL) at Weeks 0 and 4. 90-mg group: s.c. treatment with CNTO 1275 90 mg (1.0 mL) and placebo (0.5 mL)at Weeks 0 and 4. [Active-drug treatment period &lt;Weeks 12-64&gt;]: 45-mg group: s.c. treatment with placebo (0.5 mL and 1.0 mL) at Week 12, followed by s.c. treatment with CNTO 1275 45 mg (0.5 mL) and placebo (1.0 mL) at Week 16. Subsequently, s.c. treatment with CNTO 1275 45 mg (0.5 mL) and placebo (1.0 mL) every 12 weeks up to Week 52. 90-mg group: s.c. treatment with placebo (0.5 mL and 1.0 mL) at Week 12, followed by s.c. treatment with CNTO 1275 90 mg (1.0 mL) and placebo (0.5 mL) at Week 16. Subsequently, s.c. treatment with CNTO 1275 90 mg (1.0 mL) and placebo (0.5 mL) every 12 weeks up to Week 52. Placebo group: At Weeks 12 and 16, s.c. treatment with CNTO 1275 and placebo in patients divided into the following 2 groups. Subsequently, s.c. treatment with CNTO 1275 at the same dose and placebo every 12 weeks up to Week 52. Placebo group A: CNTO 1275 45 mg (0.5 mL) and placebo (1.0 mL). Placebo group B: CNTO 1275 90 mg (1.0 mL) and placebo (0.5 mL). The sorting to the Placebo group A or Placebo group B will be already determined at the time of allocation conducted at registration. In addition the pharmacokinetics (including the measurement of serum anti-CNTO 1275 antibodies) will be assessed. The investigator will handle any untoward medical event (including abnormal changes in laboratory data) that occurred in patients from after informed consent to the end of follow-up period as an adverse event, and conduct the safety assessment. The information of adverse events (any untoward medical event that occurs in subjects administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product), adverse reactions any deleterious and unintended reactions (including laboratory test abnormalities) and injection site reaction&#65341;will be collected for safety assessments. Placebo (PLA)-controlled period: 1) CNTO 45 mg: CNTO 45 mg (0.5mL) + PLA (1.0ml), 2) CNTO 90 mg: CNTO 90 mg (1.0mL) + PLA (0.5ml), 3) PLA: PLA (0.5 and 1.0 ml) Active period:1) CNTO 45 mg: PLA (0.5 + 1.0mL) at Week 12, CNTO 45 mg at Week16, CNTO 45 mg + PLA (1.0) every 12 weeks up to 52 weeks, 2)CNTO 90 mg: PLA(0.5+1.0mL) at Week12, CNTO 95 mg at Week16, CNTO 90 mg + PLA (1.0) every 12 weeks up to 52 weeks, 3) PLA-a: CNTO 45 mg + PLA (1.0ml), 4) PLA-b: CNTO 90 mg + PLA (0.5ml).</p>\n', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:dc18b24c4d23dfd735a1bba0060bbb2e' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Patients diagnosed with psoriasis (psoriasis vulgaris and psoriatic arthritis) at least 6 months before the subject registration</li>\n<li>Patients with plaque type psoriasis covering at least 10% of total body surface area (BSA) at the time of informed consent and at registration</li>\n<li>Patients with a PASI score of &gt;=12 at the time of informed consent and at registration</li>\n<li>If the patients are females of childbearing potential or males whose partner can be pregnant, the patients must agree that he/she will continuously take an appropriate contraceptive measure such as condoms and oral contraceptives for 1 year from the day of informed consent for 1 year to termination of the final investigational treatment. In the case of females who can be pregnant, the result of pregnancy test at screening must be negative</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Patients with guttate psoriasis, erythrodermic psoriasis, or pustular psoriasis</li>\n<li>Patients with a medical history of tuberculosis infection, or with suspected of tuberculosis infection</li>\n<li>Patients with present illness of chronic or recurrent infection (e.g., chronic or recurrent urinary tract infection or respiratory infection) or a past history of this</li>\n<li>Patients with a present illness of serious infection (e.g., sepsis, hepatitis, pneumonia or pyelonephritis) or those who experienced the serious infection within 2 months before registration. This includes patients with experience of intravenous administration of antibiotics or antiviral agents for infection within 2 months before registration</li>\n<li>Patients with a present illness of malignant tumors or a past history of them (except for basal cell carcinoma, intraepidermal squamous cell carcinoma in the skin and squamous cell carcinoma of the cervix, whose treatment was completed and no sign suggesting a recurrence has been observed, and squamous cell carcinoma in the skin whose treatment was completed and no sign suggesting a recurrence has been observed in the past 5 years)</li>\n</ul>\n</p>', created = 1283574893, expire = 1283661293, headers = '', serialized = 0 WHERE cid = '1:b97c3c159334db3074d9757ebe1bfab6' in /persistent/html/includes/cache.inc on line 109.

Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer

Trial phase: 
Phase III
Recruitment status: 
Recruiting

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of selenium may keep bladder cancer from growing or coming back. It is not yet known whether selenium is more effective than a placebo in preventing cancer recurrence in patients with bladder cancer. PURPOSE: This randomized phase III trial is studying selenium to see how well it works compared with a placebo in preventing cancer recurrence in patients with bladder cancer.

Background information
Trial ID: 
NCT00729287
Other unique IDs: 
CDR0000602239
UZG-CUL-UHG-Non-Invasive Bladd
EU-20870
Official title: 

Phase III Randomized Chemoprevention Study of Selenium on the Recurrence of Non-Invasive Bladder Cancer

Detailed description: 

OBJECTIVES: Primary

  • To determine the effect of selenium, when administered with standard care, in preventing the recurrence of bladder cancer in patients with non-muscle-invasive transitional cell carcinoma of the bladder at risk for recurrence.

Secondary

  • To determine the effect of selenium on the recurrence of bladder cancer, in terms of histological type, number, and size.

Number to be enrolled: 
900 patients

Palifermin in Preventing Oral Mucositis Caused by Chemotherapy and/or Radiation Therapy in Young Patients Undergoing Stem Cell Transplant

Trial phase: 
Phase II
Recruitment status: 
Not yet recruiting

RATIONALE: Palifermin may help relieve or prevent oral mucositis caused by chemotherapy and radiation therapy in young patients undergoing stem cell transplant. PURPOSE: This randomized phase II trial is studying palifermin to see how well it works compared with a placebo in preventing oral mucositis caused by chemotherapy and/or radiation therapy in young patients undergoing stem cell transplant.

Background information
Trial ID: 
NCT00728585
Other unique IDs: 
CDR0000588622
COG-ACCL0521
Official title: 

A Group-Wide Double-Blind Randomized Placebo-Controlled Trial of Palifermin to Prevent Chemotherapy and/or Radiotherapy Induced Oral Mucositis in Children Undergoing Autologous or Allogeneic Hematopoietic Stem Cell Transplantation

Detailed description: 

OBJECTIVES: Primary

  • To compare whether palifermin versus placebo administered to pediatric patients three days prior to conditioning and three days after autologous or allogeneic hematopoietic stem cell transplantation (HSCT) is associated with a reduction in the incidence of WHO grade 3 or 4 oral mucositis.

Number to be enrolled: 
200 patients

PPhase II Study on Patients With Acute Exacerbation of Schizophrenia

Phase II study in patients with acute exacerbation of schizophrenia. The primary objective is to evaluate the efficacy via the changes from baseline in the total Positive and Negative Syndrome Scale (PANSS) score of three fixed doses of JNJ-37822681 compared with placebo after 6 weeks' treatment in patients with schizophrenia

Background information
Other unique IDs: 
CR014737

A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Trial phase: 
Phase III
Recruitment status: 
Active, not recruiting

The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is to evaluate the pharmacokinetics of golimumab.

Background information
Trial ID: 
NCT00727987
Other unique IDs: 
CR015340
Official title: 

A Study of Golimumab (CNTO 148) Administered in Combination With Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis

Detailed description: 

This clinical study is scheduled to be performed for the purpose of evaluating the safety and effectiveness of golimumab (CNTO148) administered in combination with stable dose (6-8mg/week) of methotrexate (MTX) to patients with rheumatoid arthritis (RA). CNTO148 50 mg group: CNTO148 50 mg SC injections every 4 weeks from the first administration until week 152. If early escape, 100 mg SC injections every 4 weeks from week 16 until week 152.

Number to be enrolled: 
240 patients

Comparison Of The Analgesia Obtained By Infiltration For The Joinings Of Episiotomies (Liropep)

Trial phase: 
Phase IV
Recruitment status: 
Completed

Lateral episiotomy is a current care practiced with childbirth room. One of the problems encountered with this surgical act is the residual pain on perineal scar level. Maximal during the first 24 hours, this pain can persist several days or several weeks hampering to variable degrees a normal recovery of autonomy and comfort of life. Some studies have shown the interest of ropivacaine, local anaesthetic with a long action's duration for proctologic surgeries and for the cure of inguinal hernia. A recent study shown the ropivacaine perineal infiltration used prior perineorrhaphy allows an absence of post-partum pain for 24 to 27% of cases and a first analgesics request delayed to ten hours. Methodology: 165 parturients having an epidural analgesia and an episiotomy were enrolled. The perineal infiltration was randomized according to 3 equal groups (placebo, ropivacaine 0,75%, lidocaine 1%) and realised prior perineorrhaphy. then The parturient were followed during the 24 first hours. This study was designed as double blind and the study conduct was standardized in order to get only variable such as the episiotomy infiltration.

Background information
Trial ID: 
NCT00727935
Other unique IDs: 
CHU P 2006-03
Official title: 

Comparison Of The Analgesia Obtained By Infiltration Of Lidocaïne 1% And Ropivacaïne 0,75% Versus Placebo For The Joinings Of Episiotomies Among Parturients Under Epidural Analgesia

Detailed description: 

 

Number to be enrolled: 
165 patients
Acronym: 
LiRoPep

A Split-Blind Clinical Investigation to Compare the Performance and Safety of Inion GTR™ Biodegradable Membrane System to Resorbable Bilayer Bio-Gide®-Membrane of Geistlich Biomaterials in Enhancing Bone Regeneration After Removal of Wisdom Teeth.

Trial phase: 
Phase IV
Recruitment status: 
Completed

The purpose of this study was to evaluate by histology and histomorphometry, thirty human osseous biopsies sampled from fifteen patients (2 biopsies per patient) following 3 months of implantation. This study is part of a splitting-blind clinical investigation to compare the performance and safety of INION GTRTM Biodegradable Membrane System to resorbable bilayer Bio-Gide®-membrane of Geistlich biomaterials in enhancing bone regeneration after removal of wisdom teeth. The bone defect and alveolar cavity were augmented with Spongostan® dental 1x1x1cm, Johnson & Johnson, Spreitenbach, Switzerland. The extraction sites were covered on one side with an INION GTRTM Biodegradable Membrane System and on the other with Geistlich resorbable bilayer Bio-Gide®-membrane. This study was conducted in adaptation to the ISO 10993 Standard : Biological Evaluation of Medical Devices, Part 6 (2007): Tests for Local Effects after Implantation. This study was conducted in accordance with the requirements of the FDA (Department of health and human services) Good Laboratory Practice (GLP) Regulations, 21 CFR 58 (revised as of April 01, 2005) and in accordance with the requirements of the OECD Good Laboratory Practices, reference ENV/MC/CHEM (98) 17, adapted by council on November 26th 1997.

  • Trial with medical device

Background information
Trial ID: 
NCT00727818
Other unique IDs: 
R304 - 002
Official title: 

 

Detailed description: 

 

Number to be enrolled: 
0 patients

Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms

Trial phase: 
Phase III
Recruitment status: 
Completed

The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients.

Background information
Trial ID: 
NCT00727129
Other unique IDs: 
P04-001
Official title: 

Placebo-Controlled, Randomized, Double-Blind, Multicenter Study, to Demonstrate the Efficacy of 12 Weeks of Treatment With USL-221 on Moderate to Severe Vasomotor Symptoms and Vulvar/Vaginal Atrophy in Postmenopausal Patients

Detailed description: 

 

Number to be enrolled: 
495 patients

Subcutaneous Botulinum Toxin for Cutaneous Allodynia

Recruitment status: 
Recruiting

Superficial injection of Botulinum toxin has been advocated for cosmetic purposes but has also been reported to be helpful for some pain conditions. We have observed prolonged profound analgesia following subcutaneous superficial injection of Botulinum Toxin Type A (BTA) in patients with certain types of neuropathic pain. We propose to study if addition of BTA extends pain relief compared to placebo when injected subcutaneously into areas of cutaneous allodynia (the property that a normally non-noxious stimulus is perceived as painful).

Background information
Trial ID: 
NCT00725322
Other unique IDs: 
SU-01072008-965
11830
Official title: 

Subcutaneous Botulinum Toxin for Cutaneous Allodynia

Detailed description: 

Post-surgical neuromatous pain patients have marked cutaneous allodynia. Touching their skin with normally non-painful stimuli results in pain. Injected local anesthetics are often effective in providing temporary relief. In the course of clinical practice we have observed that a number of patients with cutaneous allodynia have had marked persistent benefit from subcutaneous injection of Botulinum toxin Type A. Rather than killing targeted neurons, Botulinum toxin type A inhibits release of acetylcholine from cholinergic nerve terminals in a prolonged but ultimately reversible manner.

Number to be enrolled: 
33 patients

Treatment of Schizoaffective Disorder Using Mifepristone

Trial phase: 
Phase III
Recruitment status: 
Recruiting

This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.

Background information
Trial ID: 
NCT00725270
Other unique IDs: 
SU-06012008-1191
76458
Official title: 

Treatment of Schizoaffective Disorder Using Mifepristone

Detailed description: 

You are invited to participate in a research study which evaluates the effectiveness of mifepristone (RU 486) in rapidly reducing the symptoms associated with schizoaffective disorder. Our group believes that the cognitive deficits (a decline in the ability to think clearly) and psychosis (hallucinations or delusions) exhibited in some affective disorders are driven by an excess of stress hormone effects (hypercortisolemia). Often the origin of this hormonal imbalance is unknown.

Number to be enrolled: 
30 patients

A Verification Study of CNTO 1275 in Patients With Plaque Psoriasis

Trial phase: 
Phase III
Recruitment status: 
Active, not recruiting

The purpose of this study is to assess the effectiveness and safety of CNTO 1275 in patients with moderate to severe plaque type psoriasis in subcutaneous administration of 45 and 90 mg at weeks 0 and 4 and then every 12 weeks, using placebo as a control.

Background information
Trial ID: 
NCT00723528
Other unique IDs: 
CR015166
JNS009-JPN-02
Official title: 

A Placebo-Controlled Double-Blind Comparative Study of CNTO1275 in Patients With Plaque Type Psoriasis

Detailed description: 

This is a multicenter, randomized (patients assigned study drug by chance), double-blind (neither the patient nor the physician knows the assigned medication name), placebo-controlled, parallel-group comparison study. This study has been planned to examine the effectiveness and safety of CNTO 1275 in Japanese patients with moderate to severe plaque type psoriasis in subcutaneous administration of the drug using placebo as a control.

Number to be enrolled: 
150 patients
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